As a Quality Specialist for Quality Systems, you will play a crucial role in supporting the quality systems activities at our client site in Tipperary. This is an 11-month initial contract opportunity.
Key Responsibilities:
* Ensure timely and effective completion of quality systems core functions in accordance with schedules and policies.
* Participate as a member of the Quality Systems Team and provide leadership through knowledge and skill regarding validation standards.
* Approve all validation documentation and ensure compliance to MMD policies, procedures, and guidelines.
* Support the implementation of site or capital projects by defining validation requirements and providing technical assistance.
* Develop Validation Summary Reports and assist in developing overall Quality plans for major projects.
* Work with other areas in MMD and industry to predict future trends in validation and determine best practices.
Quality Assurance Activities:
* SAP Quality Process Steward: Provide Quality and change analyst review for all change requests through all stages of the change control process.
* Laboratory QA Oversight: Support and approve the systems supporting laboratory functions, instrumentation, and GLIMS.
* Stability Oversight: Review and approval of stability reports, including intermediate and API stability data and reports.
* Microbiology Point of Contact: Liaise with site Microbiologist for all microbial issues, such as water, utilities, environment, excipients, or products.
System Management:
* Manage the site inventory of Quality Agreements to ensure they are raised for all required relationships.
* Interact and communicate with SD&PM, relevant stakeholders, and external parties to ensure appropriate Quality Agreements are current, approved, on file, and retrievable.
* Annual Review System Management: Manage the system ensuring that Annual Reviews (AR/APR/PQR) for products and systems, including automation, are completed to meet the Annual Review schedule.
Quality Council and Supplier Change Evaluations:
* Manage the annual quality council schedule, monthly quality council agenda, minutes, and action follow-up.
* Review and approve Supplier Change Evaluation documentation, complete/approve MDS updates post SCE approval, and generate quality/technical agreements with suppliers as necessary.
Filing & Licence Maintenance and Regulatory Requests Follow-ups:
* Review and ongoing maintenance of site licences.
* Provide site documentation to support product filings in accordance with CMC requests.
* QA Regulatory Data: Review and verify documentation that may be used for submission to Pharm - CMC or other requester(s) for regulatory submissions/filings.
Audit Program and Special Features:
* Support the internal GMP walk-down and scheduled audits program.
* Host site Regulatory Inspections.
* Operate as part of a self-directed team, carrying out day-to-day functions, assigning priorities, and monitoring performance metrics.
* Promote GMP awareness at the Ballydine site.
Requirements:
* MMD and site quality policies, procedures, and guidelines relating to the Quality Assurance function and plant quality systems.
* Relevant GMP standards, global engineering standards, and plant procedures and policies.
* Plant equipment and unit operations, plant layout, and plant documentation.
* Laboratory testing and documentation, validation principles, and guidelines.
Qualifications and Education: A minimum of a degree or post-graduate qualification in Science, Pharmacy, or Engineering field.